A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Summary

This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of englumafusp alfa (RO7227166) in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). Englumafusp alfa will be administered by intravenous (IV) infusion in combination with obinutuzumab and in combination with glofitamab. A fixed dose of obinutuzumab (Gpt; pre-treatment) will be administered up to seven days prior to the first administration of englumafusp alfa and seven days prior to the first administration of glofitamab. This entry-into-human study is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage (Part III).

Timeline

Start

2019-08-13

Primary completion

2027-03-31

Completion

2027-03-31

Publications

• Hutchings M, Dickinson M, Gritti G, Carlo-Stella C, Townsend W, Bosch F, Bartlett NL, Cartron G, Ghesquieres H, Houot R, Walter H, Offner F, Dimier N, Jamois C, Herter S, Keelara A, Wilson S, Gallien J, Hinton H, Gonzalez-Albo IP, Korfi K, Kazantzidis G, Wasmer MH, Lechner K, Morschhauser F. Englumafusp alfa plus glofitamab in B cell non-Hodgkin lymphoma: a phase 1 trial. Nat Med. 2026 Jul 16. doi: 10.1038/s41591-026-04533-0. Online ahead of print.

Drugs

Indications